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Upcoming Webinars
Rapid Delivery of API Enables Accelerated IND Application – Challenges and Solutions
Wednesday, June 7, 2023
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Process development runs through the entire life cycle of new drug development and plays important roles in each stage. However, as the purpose of each development stage changes, the priority of the process development also changes accordingly. For the IND stage, the main purpose of process development is to scout the most efficient way within a limited timeline to produce the API, ensuring timely toxicology study and subsequent clinical trials. Therefore, rapid delivery of API is crucial for a timely IND submission.     In this webinar, we will discuss the importance of phase-appropriate process development and various frequent-encountered challenges in process development during the IND filing stage. These risks include scalability difficulties resulting from an inappropriate medicinal chemistry process; process safety issues; unanticipated risks of residual PGI/elemental impurities; API delivery delays caused by inappropriate specification settings; and scheduling challenges in delivering tox batches within restricted timeframes. With case studies, we will dive into these challenges in detail and share our experience in resolving them.     Key Learning Objectives: The importance of phase-appropriate process development for IND filing  Common obstacles and difficulties in process development  Who Should Attend: Early-Stage Drug Developers  R&D Scientists Brought to you by: Speakers: Renyun Guo, Ph.D. Senior Director, API Process Development, WuXi STA Ji Qi, Ph.D. Senior Principle Scientist, Discovery Process Chemistry Lead, MSD Ann Thayer Contributing Editor, C&EN Media Group
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Analyzing Protein Developability and Stability at High-Throughput
Tuesday, June 13, 2023
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Understanding the biophysical state, quality and properties of biopharmaceuticals is essential in product and process development. However, available material, time and resources are often limiting.   Dynamic light scattering (DLS) is an industry standard technique for protein formulation, particle sizing and stability studies. This webinar will illuminate how high-throughput DLS (HT-DLS), performed in low-volume microwell plates, is used to understand aggregation as well as colloidal and thermal stability of therapeutic protein candidates and formulations. Application examples include various studies of freeze-thaw, formulation buffer screening and thermal stability.   Key Learning Objectives: Background and instrumentation for HT-DLS How DLS is used to study aggregation under applied stresses How DLS evaluates protein colloidal stability via second virial coefficient A 2  and the diffusion interaction parameter k D . Who Should Attend: Biopharma product development scientists in need of automated methods for characterizing protein stability Formulation lab managers seeking to improve productivity with high-throughput DLS instrumentation   Brought to you by:   Speakers: Felix Gloge, Ph.D. Field Application Scientist, Wyatt Technology Christian Sieg, Ph.D. Application Scientist, Wyatt Technology Melissa O'Meara Forensic Science Consultant, C&EN Media Group
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The Predict-First Paradigm: How Digital Chemistry is Changing Drug Discovery
Wednesday, June 21, 2023
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Drug discovery chemists often ask two common questions: “What is the most efficient way to test my hypothesis?” and “How can I iterate on my ideas quickly?”    Digital chemistry offers a modern paradigm for answering these questions by enabling rapid in silico testing of design ideas using highly accurate digital assays of key properties, accessible across whole project teams. This shift from design strategies based largely on experimental trial and error towards a ‘predict-first’ approach to drug discovery allows teams to dramatically expand the pool of molecules that can be explored and results in a highly interactive and fully in silico design-make-test-analyze (DMTA) cycle. Chemists are empowered to test hypotheses through predictive modeling and iteratively improve designs prior to compound synthesis. Teams can confidently spend time and energy exploring new, unknown, and often more complex designs while sending only the top performing molecules for synthesis.    In this webinar, we will walk through the digital chemistry strategy used by Schrödinger’s Therapeutics Group, which has led to several successful clinical-stage drug candidates. We will demonstrate how this strategy is based in LiveDesign, Schrödinger’s cloud-native, collaborative enterprise informatics platform, which empowers teams to design, computationally assess, and prioritize new compounds together in real-time.     Key Learning Objectives: Predict properties: Understand how computationally-guided molecular design and a predict-first strategy can accelerate and improve your small molecule drug discovery process  Centralize technology: See how Schrödinger scientists used a digital chemistry platform to enhance crowdsourced ideation and team collaboration Overcome collaboration hurdles: Learn how a centralized platform for molecular design and discovery can increase project efficiency by securely and easily sharing data with internal and external CRO partners  Who Should Attend: Medicinal Chemists  Synthetic Chemists  Computational Chemists Digitization Managers  Research IT R&D Leadership  Brought to you by: Speakers: Eugene Hickey Senior Research Leader, Therapeutics Group, Schrödinger, Inc.   Alice Hooper Senior Scientist, Therapeutics Group, Schrödinger, Inc. Wade Miller Senior Scientist, Schrödinger, Inc. Olivia Lynes Strategic Deployment Manager, Schrödinger, Inc. Catherine Dold Health & Environment Writer, C&EN Media Group
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Understanding the Importance of Solid Form Screening in Drug Development
Wednesday, June 28, 2023
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Solid state properties of active pharmaceutical ingredients (API) are a critical attribute of any drug product and significantly impact the drug’s efficacy, safety, and stability. The selection, development and scaling-up of a solid-state form with desirable properties is therefore critical for the success of drug development programs.   This webinar aims to highlight the significance of solid form in drug substance development. The webinar will feature a case study that demonstrates the importance of solid form screening and optimization to identify the most stable form of a drug substance. Following this, the crystallization process development will be discussed, focusing on improving particle properties and purity. The webinar will also discuss considerations around scale-up, drying methodology, and other unit-operations such as wet-milling and their impact on particle properties.   Key Learning Objectives: Understand importance of solid form in API development Learn how to analyze and interpret appropriate data  Highlight how multi-site collaboration and knowledge transfer results in a superior product  Who Should Attend: Those involved in pharmaceutical R&D Those involved in solid-state chemistry R&D Chemical Engineers Brought to you by: Speakers: Dr. Alexander Thom Crystallization Team, Cambrex Edinburgh Jeff Huber Contributing Editor, C&EN Media Group
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Essential Analytical Techniques for Food Powder Characterization: From R&D to Manufacturing
Tuesday, July 11, 2023
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A thorough knowledge of size, porosity, and surface area is important in characterizing food powders. Furthermore, predicting the flow behavior of food powders is important to ensure no unexpected issues are encountered during handling in industrial processing.This webinar will focus on technologies that enable powder size, surface area, porosity, and flow evaluation (via powder rheology). A good understanding of these powder parameters, along with the flowability of the powders, paves the way towards optimizing process conditions to achieve a quality final product.     Effects of both internal influences like particle shape, size, size distribution, density, as well as external influences like humidity, temperature, and degree of consolidation, will be highlighted for end product usage and flow behavior of food products through several case studies.    Key Learning Objectives: How intrinsic material attributes affect a sample’s processability The impact of environmental conditions, such as temperature, humidity, and consolidation on final product attributes Essential tools and techniques for the characterization of food powders Who Should Attend: Anyone working in Food Research & Development, or Food Science  Food Manufacturers, Quality Control/Assurance Brought to you by:   Speakers: Dr. Brian Rodenhausen Particle and Materials Characterization Lead Scientist, Anton Paar Dr. Abhishek Shetty Advanced Technical Center Lead Scientist, Anton Paar Kelly McSweeney Contributing Editor, C&EN Media Group
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